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Good morning! Today, we talk a whole lot about RFK Jr., and also President-elect Donald Trump. Plus, we note that GLP-1 drugs can increase a person’s risk of aspiration when undergoing surgery. Have a nice week!
From hospitals to biopharma, change is coming
It’s hard to know exactly what change in Washington will mean for the health care industry starting next year. But we have some pretty good clues.
Among the possibilities: Newly empowered Republicans could tweak the Medicare drug price negotiation program in ways that could be more to the liking of biopharma companies. Other changes may not be as welcomed by the industry: If President-elect Donald Trump’s surrogate Robert F. Kennedy Jr. has his way, get ready for even more anti-pharma rhetoric and potential instability at the Food and Drug Administration.
Are television drug advertisements also on the line? There are reasons to think that won’t be the case.
Read more from STAT’s Rachel Cohrs Zhang, Bob Herman, and Tara Bannow.
Risk of aspiration during surgery added to GLP-1 drug labels
From STAT’s Elaine Chen: Earlier this month, the FDA updated the labels of GLP-1 drugs to warn of the risk of patients breathing food into their lungs, also known as aspiration, while undergoing sedation or anesthesia for medical procedures.
Typically, patients fast before surgeries to prevent this risk. But GLP-1 drugs delay gastric emptying, and there have been rare reports of patients who still had food in their stomachs even while following standard fasting guidelines and experienced aspiration, according to the FDA’s update.
The drugs whose labels were updated include Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro.
The agency said, however, that there’s not yet enough data to make recommendations on how to mitigate this risk, such as whether fasting guidelines should be changed or whether patients should temporarily stop taking the drugs.
Doctors have debated how big of a risk this is and how to handle it. The American Society of Anesthesiologists has suggested that patients should stop taking the treatments ahead of procedures, while the American Gastroenterological Association has said there is insufficient evidence for a formal guideline and suggested doctors should evaluate each patient individually.
Will oversight of supplements get even looser?
Robert F. Kennedy Jr.’s potential influence on the Trump administration’s health agenda could stretch to dietary supplements. Kennedy is well known for his anti-vaccine stances and his support for alternative therapies. He’s openly criticized the FDA and has called for an end to the regulatory oversight of many health products, including supplements and nutraceuticals.
This shift could allow the supplement industry, which is known for promoting unverified and sometimes harmful products, to operate with less scrutiny, two nutrition experts opine in a new First Opinion essay.
“The supplements industry is wealthy and ruthless,” they write. “Not only do they market their products with a menagerie of deceptive claims, but they are also flooding statehouses with disinformation and waging a full-out attack on scientific research and researchers like us.”
Brian Skorney and Daphne Zohar weigh in on Trump
In case you missed it, biotech analyst Brian Skorney and industry veteran Daphne Zohar joined “The Readout Loud,” STAT’s delightful podcast, to discuss how the Trump administration might affect the FDA, the biotech industry, and the stock market. We’re offering up a transcript of some of the illuminating things they had to say.
For instance, Skorney discussed former biotech executive turned political candidate Vivek Ramaswamy as one individual who’s in Trump’s ear regarding health care: “He’s a super smart guy, understands the regulation side of things, understands drug development,” Skorney said. “I think [Vivek] would hopefully be a more cool-headed person to kind of make recommendations here.”
Zohar argued that certain “Wild West” scenarios — like the FDA losing oversight or childhood vaccines being banned are “really very unlikely to be happened.” But she does think that issues of women’s health and gender-affirming care are under threat.
MAHA surfaces nominees for health care positions
Speaking of RFK Jr., he’s launched a webpage called “Nominees for the People” to crowdsource candidates for health-related government positions in the Trump administration, STAT’s Isabella Cueto reports. His “Make America Healthy Again” initiative favors candidates who have anti-establishment, wellness-oriented views that are often critical of mainstream medicine.
High-profile nominees include Casey Means, a nutrition-focused functional medicine doctor who is reportedly being considered for an FDA post. Also on the list is Simone Gold, who founded America’s Frontline Doctors, the right-wing physician group that rallied against Covid vaccines and protocols and promoted ivermectin and hydroxychloroquine as treatments. She’s also known for illegally entering the U.S. Capitol on Jan. 6, 2021, after Trump’s failed reelection bid nearly four years back.
More reads
- What medtech CEOs are saying this week about Trump’s potential tariffs, FierceBiotech
- Autolus Therapeutics gets FDA approval for cancer treatment, MarketWatch
- Pharma giant GSK is quitting BIO in latest setback for the lobbying group, STAT
- Pfizer makes $1 billion commitment in China to boost innovation, targets Chinese market, BioSpace